NCT03430193

Brief Summary

A number of studies for clinical pathway (CP) after hip fracture have been suggested to improve post-fracture outcome. However, CP is not carried out properly in most countries due to inadequate system and awareness, and lack of interdisciplinary approach among orthopaedists, geriatricians and rehabilitation specialists. Thus, we developed Fragility fracture integrated rehabilitation management (FIRM), a new standardized guideline and the multidisciplinary fragility fracture care based on the clinical rehabilitation pathway and conducted a prospective study to evaluate the effects of FIRM compared to conventional rehabilitation.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
288

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 5, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 12, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

February 12, 2018

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
Last Updated

January 15, 2021

Status Verified

January 1, 2021

Enrollment Period

3.6 years

First QC Date

January 5, 2018

Last Update Submit

January 14, 2021

Conditions

Hip Fractures

Keywords

rehabilitationmulti-disciplinary rehabilitationclinical pathwayFragility

Outcome Measures

Primary Outcomes (1)

  • Change from baselines mobility status (Functional Ambulatory Category (FAC)) after rehabilitation

    range, 0 to 5; decreasingly worse

    0, 3 month, 6 month, 12 month

Secondary Outcomes (10)

  • Change from baselines mobility status (KOVAL) after rehabilitation

    0, 3 month, 6 month, 12 month

  • Change from baselines mobility status (Functional Independence Measure (FIM)- locomotion) after rehabilitation

    0, 3 month, 6 month, 12 month

  • Change from baselines balance and fall risk (Berg Balance Scale (BBS)) after rehabilitation

    0, 3 month, 6 month, 12 month

  • Change from baselines from cognition (Korean Mini-Mental State Examination (K-MMSE)) after rehabilitation

    0, 3 month, 6 month, 12 month

  • Change from baselines from mood (Korean version of the Geriatric Depression Scale (GDS)) after rehabilitation

    0, 3 month, 6 month, 12 month

  • +5 more secondary outcomes

Other Outcomes (2)

  • Mortality

    0, 3 month, 6 month, 12 month

  • Recovery to premorbid ambulatory status

    0, 3 month, 6 month, 12 month

Study Arms (3)

FIRM group

EXPERIMENTAL

FIRM program consisted of total 10 days session including PT, in two times twenty-minute sessions per day and 4 times OT during admission initiated before transfer to rehabilitation ward. PT (Weight bearing exercise, strengthening exercise, gait training, aerobic exercise and functional training) progressed gradually based on individual functional level and OT of activities of daily life (ADL) training (transfer, sit to stand, bed mobility, dressing, self-care retraining and using adaptive equipment) was provided.

Other: FIRM

Conventional group

ACTIVE COMPARATOR

Conventional rehabilitation program consisted of total 10 days session of PT focused on simple standing and gait training, in one time twenty-minute sessions per day.

Other: Conventional rehabilitation

No-rehabilitation group

NO INTERVENTION

Discharged patients not transferred to rehabilitation unit after surgery for hip fracture.

Interventions

FIRMOTHER

FIRM program consisted of total 10 days session including PT, in two times twenty-minute sessions per day and 4 times OT during admission initiated before transfer to rehabilitation ward. PT (Weight bearing exercise, strengthening exercise, gait training, aerobic exercise and functional training) progressed gradually based on individual functional level and OT of activities of daily life (ADL) training (transfer, sit to stand, bed mobility, dressing, self-care retraining and using adaptive equipment) was provided.

FIRM group
Conventional rehabilitationOTHER

Conventional rehabilitation program consisted of total 10 days session of PT focused on simple standing and gait training, in one time twenty-minute sessions per day.

Conventional group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Type of fracture : Femoral neck, intertrochanteric, subtrochanteric fracture
  • Type of surgery : Bipolar hemiarthroplasty, THA, ORIF

You may not qualify if:

  • Surgery not for hip fracture, but for infection, arthritis, implant loosening, AVN
  • Femur Shaft fracture, acetabular fracture, periprosthetic fracture, pathologic fracture for tumor
  • Combined multiple fracture (ex. Upper extremity)
  • Revision operation
  • Disagree to participation for clinical trial
  • Severe cognitive dysfunction (Obey command ≤1)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

RECRUITING

Related Publications (10)

  • Beaupre LA, Cinats JG, Senthilselvan A, Lier D, Jones CA, Scharfenberger A, Johnston DW, Saunders LD. Reduced morbidity for elderly patients with a hip fracture after implementation of a perioperative evidence-based clinical pathway. Qual Saf Health Care. 2006 Oct;15(5):375-9. doi: 10.1136/qshc.2005.017095.

    PMID: 17074877BACKGROUND

  • Lyons AR. Clinical outcomes and treatment of hip fractures. Am J Med. 1997 Aug 18;103(2A):51S-63S; discussion 63S-64S. doi: 10.1016/s0002-9343(97)90027-9.

    PMID: 9302897RESULT

  • Magaziner J, Fredman L, Hawkes W, Hebel JR, Zimmerman S, Orwig DL, Wehren L. Changes in functional status attributable to hip fracture: a comparison of hip fracture patients to community-dwelling aged. Am J Epidemiol. 2003 Jun 1;157(11):1023-31. doi: 10.1093/aje/kwg081.

    PMID: 12777366RESULT

  • Sellier E, Labarere J, Sevestre MA, Belmin J, Thiel H, Couturier P, Bosson JL; Association pour la Promotion de l'Angiologie Hospitaliere. Risk factors for deep vein thrombosis in older patients: a multicenter study with systematic compression ultrasonography in postacute care facilities in France. J Am Geriatr Soc. 2008 Feb;56(2):224-30. doi: 10.1111/j.1532-5415.2007.01545.x. Epub 2007 Dec 7.

    PMID: 18070003RESULT

  • Hannan EL, Magaziner J, Wang JJ, Eastwood EA, Silberzweig SB, Gilbert M, Morrison RS, McLaughlin MA, Orosz GM, Siu AL. Mortality and locomotion 6 months after hospitalization for hip fracture: risk factors and risk-adjusted hospital outcomes. JAMA. 2001 Jun 6;285(21):2736-42. doi: 10.1001/jama.285.21.2736.

    PMID: 11386929RESULT

  • Siu AL, Penrod JD, Boockvar KS, Koval K, Strauss E, Morrison RS. Early ambulation after hip fracture: effects on function and mortality. Arch Intern Med. 2006 Apr 10;166(7):766-71. doi: 10.1001/archinte.166.7.766.

    PMID: 16606814RESULT

  • Koval KJ, Cooley MR. Clinical pathway after hip fracture. Disabil Rehabil. 2005 Sep 30-Oct 15;27(18-19):1053-60. doi: 10.1080/09638280500056618.

    PMID: 16278174RESULT

  • Halbert J, Crotty M, Whitehead C, Cameron I, Kurrle S, Graham S, Handoll H, Finnegan T, Jones T, Foley A, Shanahan M; Hip Fracture Rehabilitation Trial Collaborative Group. Multi-disciplinary rehabilitation after hip fracture is associated with improved outcome: A systematic review. J Rehabil Med. 2007 Sep;39(7):507-12. doi: 10.2340/16501977-0102.

    PMID: 17724548RESULT

  • Adunsky A, Lusky A, Arad M, Heruti RJ. A comparative study of rehabilitation outcomes of elderly hip fracture patients: the advantage of a comprehensive orthogeriatric approach. J Gerontol A Biol Sci Med Sci. 2003 Jun;58(6):542-7. doi: 10.1093/gerona/58.6.m542.

    PMID: 12807926RESULT

  • Lee SY, Beom J, Kim BR, Lim SK, Lim JY; Fragility Fracture Rehabilitation Study Group. Comparative effectiveness of fragility fracture integrated rehabilitation management for elderly individuals after hip fracture surgery: A study protocol for a multicenter randomized controlled trial. Medicine (Baltimore). 2018 May;97(20):e10763. doi: 10.1097/MD.0000000000010763.

    PMID: 29768364DERIVED

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Study Officials

  • Jae-Young Lim, MD, PhD

    Seoul National University Bundang Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Seung-Kyu Lim, MD

CONTACT

+821096045700flyingmango77@gmail.com

Bo-Ram KIM

CONTACT

+82317877732bboram2@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Department of Rehabilitation Medicine

Study Record Dates

First Submitted

January 5, 2018

First Posted

February 12, 2018

Study Start

February 12, 2018

Primary Completion

September 30, 2021

Study Completion

September 30, 2021

Last Updated

January 15, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)